To Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics and Metabolism of Midazolam in CML Patients With Additional Extension Phase to Evaluate the Safety of Nilotinib

Inclusion criteria

• Patients with a cytopathologically confirmed diagnosis of Ph+ CML or Philadelphia chromosome- negative (Ph-) CML patients in accelerated or chronic phase who are resistant and/or intolerant against at least one prior therapy with a BCR-ABL tyrosine kinase inhibitor
• Female or male ≥ 18 years of age
• Patients who are nilotinib naïve at study entry, e.g. did not receive any nilotinib treatment prior to study
• WHO Performance Status of ≤ 2

Exclusion criteria

• Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
• Impaired cardiac function
• History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
• Patients actively receiving therapy with the prohibited co-medications (CYP3A4 inhibitors or inducers, or CYP2C inducers)
• Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval
• Treatment with immunotherapy or chemotherapy within 3 days (6 weeks for nitrosurea or mitomycin-C) prior to Day 1 or who have not recovered from side effects of such therapy.
• Treatment with imatinib within 1 week prior to Day 1 or who have not recovered from side effects of such therapy.
• Patients who have hypersensitivity to midazolam or related compounds

Other protocol-defined inclusion/exclusion criteria may apply